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PET/MR Imaging for Cardiac Arrhythmias

Phase 2

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be ≥21 and ≤80 years of age

History of scar-mediated ventricular arrhythmia scheduled for invasive EAM-guided catheter ablation for clinical care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing whether PET-MR imaging can improve treatment for heart failure and irregular heart rate.

Who is the study for?

This trial is for adults aged 21-80 with a history of scar-mediated ventricular arrhythmia who are scheduled for ablation therapy. They must be able to consent and have no structural heart disease, MRI/PET contraindications, severe kidney issues, diabetes, lupus, or certain other conditions. Pregnant or lactating women cannot participate.Check my eligibility

What is being tested?

The study tests if PET-MR imaging can help doctors perform ablation more successfully in patients with irregular heart rates due to ventricular arrhythmias. The goal is to improve the procedure's success rate and reduce the need for repeat treatments.See study design

What are the potential side effects?

Potential side effects may include reactions to the PET-MR contrast agent like Dotarem (gadolinium-based), which could cause allergic responses or discomfort at the injection site. There might also be risks associated with exposure to radiation during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 80 years old.

Select...

I am scheduled for a procedure to treat irregular heartbeats caused by scar tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

TPP imaging in Ventricular Arrhythmia

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Treatment FailureExperimental Treatment1 Intervention

A subset of the Arrhythmia cohort, this group will undergo a second imaging session. This subset corresponds to patients from the Arrhythmia cohort presenting with recurrent ventricular arrhythmia following initial EAM-guided catheter ablation and requiring repeated ablation. It is estimated that 30% of the Arrhythmia cohort patients will require repeat ablation based on rate of repeat ablation procedures at MGH. T

Group II: ArrhythmiaExperimental Treatment1 Intervention

This cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment

Group III: ControlActive Control1 Intervention

Normal subjects without history of cardiac disease or arrhythmia

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,929 Previous Clinical Trials

13,198,271 Total Patients Enrolled

Media Library

18F-TPP Clinical Trial Eligibility Overview. Trial Name: NCT03265431 — Phase 2

Cardiac Arrhythmias Research Study Groups: Arrhythmia, Control, Treatment Failure

Cardiac Arrhythmias Clinical Trial 2023: 18F-TPP Highlights & Side Effects. Trial Name: NCT03265431 — Phase 2

18F-TPP 2023 Treatment Timeline for Medical Study. Trial Name: NCT03265431 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are those aged fifty and up able to partake in this experiment?

"The boundaries for acceptable age of enrollment are 21 and 80 respectively, as per the study's inclusion criteria."

Answered by AI

Is enrollment available to participate in this clinical research?

"A requirement for entry into this clinical investigation is that participants must suffer from arrhythmias and have a pre-existing cardiac condition. The age range of qualified individuals lies between 21 to 80 years old, with the aim of recruiting 150 patients in total."

Answered by AI

What is the scope of participants in this research endeavor?

"Indeed, the information on clinicaltrials.gov confirms that this medical study is currently recruiting participants. Initially posted on July 1st 2016 and last updated November 15th 2022, it seeks 150 patients across a single site."

Answered by AI

Are there still spots available for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently accepting participants and has been since July 1st 2016 when it was initially posted. It was last altered on November 15th 2022 with the aim of recruiting 150 patients from one site."

Answered by AI

What other experiments have utilized 18F-TPP to date?

"Currently, 1 18F-TPP trial is in progress. 0 of these trials are Phase 3 and one clinical site is located in Boston, Massachusetts."

Answered by AI

What is the security profile of 18F-TPP for human consumption?

"There is an accumulation of evidence confirming 18F-TPP's safety, thus earning a score of 2. However, as it currently stands, there has been no data pertaining to efficacy for this medication."

Answered by AI

Recent research and studies

European Journal of Nuclear Medicine and Molecular ImagingJournal

In Vivo Quantitative Mapping of Human Mitochondrial Cardiac Membrane Potential: A Feasibility Study

Pelletier-Galarneau, Matthieu, Yoann Petibon, Chao Ma, Paul Han, Sally Ji Who Kim, Felicitas J. Detmer, Daniel Yokell, et al.. 2020. “In Vivo Quantitative Mapping of Human Mitochondrial Cardiac Membrane Potential: A Feasibility Study”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-020-04878-9.

clinicaltrials.govStudy

Evaluation of PET/MR in Patients Selected for Ablation Therapy

Marc D.Normandin, Ph.D 2017. "Evaluation of PET/MR in Patients Selected for Ablation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03265431.